Ero Earwax Removal Kit

SPL v4

SPL

SPL Set ID a9904b63-27a4-205c-e053-2995a90af762

Route

AURICULAR (OTIC)

Published

Effective Date 2020-07-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (0.065 mg)

Inactive Ingredients

Chamomile Oxyquinoline Sulfate Mineral Oil Aloe Vera Leaf Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-03

Description

FOR USE IN THE EAR ONLY Adults & Children over 12 yrs of age: Tilt head to the side and place 5-10 drops into ear. Dropper tip of removal drops should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to four days if needed, or as directed by a doctor. Safely scoop out wax with removal tool. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe. Children under 12 yrs of age: Consult a doctor.

Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have:

ear drainage or discharge

ear pain

irritation, or rash in the ear

dizziness

an injury or perforation (hole) of the eardrum

recently had ear surgery

Indications and Usage

For occasional use as an aid to soften, loosen and remove excessive earwax.

Dosage and Administration

FOR USE IN THE EAR ONLY

Adults & Children over 12 yrs of age:

Tilt head to the side and place 5-10 drops into ear.

Dropper tip of removal drops should not enter ear canal.

Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.

Use twice daily for up to four days if needed, or as directed by a doctor.

Safely scoop out wax with removal tool.

Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.

Children under 12 yrs of age:

Consult a doctor.

Description

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.

Section 50566-9

Stop use and ask a doctor if:

you need to use more than four days

excessive earwax remains after use of this product

Section 50567-7

When using this product avoid contact with eyes.

Section 51727-6

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Section 51945-4

Section 55105-1

Earwax Removal Aid

Section 55106-9

Carbamide Peroxide 6.5%

Section 60561-8

Other Information

Do not use if neck wrap imprinted safety seal is broken or missing

Do not store above 25 degrees C, 77 degrees F

Store bottle in outer carton

Keep cap on bottle when not in use

Product foams on contacy with earwax due to release of oxygen

Structured Label Content

Indications and Usage (34067-9)

For occasional use as an aid to soften, loosen and remove excessive earwax.

Dosage and Administration (34068-7)

FOR USE IN THE EAR ONLY

Adults & Children over 12 yrs of age:

Tilt head to the side and place 5-10 drops into ear.

Dropper tip of removal drops should not enter ear canal.

Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.

Use twice daily for up to four days if needed, or as directed by a doctor.

Safely scoop out wax with removal tool.

Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.

Children under 12 yrs of age:

Consult a doctor.

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have:

ear drainage or discharge

ear pain

irritation, or rash in the ear

dizziness

an injury or perforation (hole) of the eardrum

recently had ear surgery

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

you need to use more than four days

excessive earwax remains after use of this product

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Earwax Removal Aid

Section 55106-9 (55106-9)

Carbamide Peroxide 6.5%

Section 60561-8 (60561-8)

Other Information

Do not use if neck wrap imprinted safety seal is broken or missing

Do not store above 25 degrees C, 77 degrees F

Store bottle in outer carton

Keep cap on bottle when not in use

Product foams on contacy with earwax due to release of oxygen

Advanced Ingredient Data

[{"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OXYQUINOLINE SULFATE", "unii": "61VUG75Y3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "0.065", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For occasional use as an aid to soften, loosen and remove excessive earwax.", "34068-7": "FOR USE IN THE EAR ONLY Adults & Children over 12 yrs of age: Tilt head to the side and place 5-10 drops into ear. Dropper tip of removal drops should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to four days if needed, or as directed by a doctor. Safely scoop out wax with removal tool. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe. Children under 12 yrs of age: Consult a doctor.", "34071-1": "Warnings Ask a doctor before use if you have: ear drainage or discharge ear pain irritation, or rash in the ear dizziness an injury or perforation (hole) of the eardrum recently had ear surgery", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.", "50566-9": "Stop use and ask a doctor if: you need to use more than four days excessive earwax remains after use of this product", "50567-7": "When using this product avoid contact with eyes.", "51727-6": "Aloe Barbadensis Leaf Extract Chamomilla Recutita (Matricaria) Flower Extract Glycerin Mineral Oil Oxyquinoline Sulfate", "55105-1": "Earwax Removal Aid", "55106-9": "Carbamide Peroxide 6.5%", "60561-8": "Other Information Do not use if neck wrap imprinted safety seal is broken or missing Do not store above 25 degrees C, 77 degrees F Store bottle in outer carton Keep cap on bottle when not in use Product foams on contacy with earwax due to release of oxygen"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:32.748002 · Updated: 2026-03-14T23:02:09.430554